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31.07.2007

Choppy waters for clinical trials in Russia

New data show Russia's clinical trials industry may have been impacted by the recent temporary biologics ban. Meanwhile the country is attempting to introduce tighter clinical trial regulations.

The country's Federal Agency for Health Care and Social Development (Roszdravnadzor) issued 114 permits to conduct clinical trials in Russia in the second quarter of this year, a 13 per cent decrease on the comparable period last year.

Dragging the figures down was a 25 per cent fall in the number of international multi-centre clinical trials being approved, according to a market analytical report released by Russia-based contract research organisation (CRO) Synergy Research Group.

"We think this decrease in international business is primarily due to the recent biologics ban," a spokesperson from Synergy told Outsourcing-Pharma.com.

At the beginning of June, the Russian Federal Customs Service (FTS) without warning shut down the export from the country of all human medical biological materials, including blood and human tissue.

"For two weeks during the ban there were no official announcements from government officials as to the situation and no one knew what was going on."

The spokesperson believes that some international companies did not submit or withdrew clinical trial applications in Russia as a result.

"If the ban hadn't occurred I think that the number of international trial approvals in the second quarter would have been at least the same as in the first quarter."

The situation has now being resolved, with things returning to as they were before the ban was implemented, said the spokesperson.

"I think business in the industry will now develop again to reach the levels it was at before. Such problems [with customs] have happened in the past and don't [tend to] affect the market in the long term."

Of the companies that were present in Russia during the second quarter, Hoffmann-La Roche was the most prominent, with 10 ongoing clinical trials at 89 sites.

According the Synergy, the leader among foreign countries participating in the Russian clinical trials market was the US (17 per cent) followed by Switzerland (11 per cent) and Germany ranking third with its 7 per cent.

Over half the trial sites being used are located in Moscow and Saint-Petersburg.

Meanwhile, new, stricter legislations are being planned by Roszdravnadzor that will more closely regulate the country's clinical trials industry.

As reported in Russian newspaper Kommersant, the Russian regulator revealed new legislation proposals at the beginning of this month that include several amendments to the law concerning the use of medications as well as clinical trials of new drugs.

Under the proposed changes, in order to run a clinical trial, a site will now be required to obtain permission for each individual trial it plans to conduct, as opposed to the old system where it was just required to undergo an accreditation procedure that would cover it for all future studies at its medical facilities.

This amendment will prevent cases in which medical researchers have been sued on the grounds that a given facility was technically not legally certified to carry out clinical trials, according to Kommersant.

In addition, Roszdravnadzor has indicated it plans to carry out interim checks at specific stages of all clinical trials being held in Russia. Any negative outcomes of these inspections could result in the trial being halted.

Furthermore, clinical trial sites will also now be legally responsible for the clinical trials that they conduct, and for the drugs that they administer.

This is because there "have been incidents in which a lack of a responsible party or a plaintiff has meant that courts have been unable to hear cases from people who have used certain medications," Roszdravnadzor consultant Mikhail Getman told Kommersant.

Meanwhile, under the proposed new legislation, permission to run a clinical trial will only be given if the drug being tested is also going to be registered in Russia once the trial is over.

"Russian medicine should benefit from the fact that Russian citizens are participating in these trials," Yurgel told Kommersant. New drugs must be registered under the name of a Russian legal entity, meaning that western pharmaceutical companies will have to transfer all of the corresponding legal rights to a Russian partner, he said.

According to Kommersant, "officials maintain that the new legislation will provide an additional level of protection for patients who participate in clinical trials of new drugs", however, many of those in the industry disagree, believing it will only introduce "many superfluous bureaucratic barriers that will hinder the process of testing new drugs in Russia".

However, the legislation, which has now been introduced in the State Duma (the country's legislative body), "is not expected to have an easy path to approval: many of the proposals included in the new regulations have already attracted the attention of the Ministry of Trade and Economic Development and the Duma's legal department", the newspaper said.

In other developments, Roszdravnadzor head Nikolai Yurgel also recently announced that legislation that would allow children to be involved in regular clinical trials in Russia may soon be introduced.

So far companies who have wanted to conduct trials in children have been required to obtain special permission from the regulator and only 75 paediatric trials (4.4 per cent of all clinical trials in Russia) have been conducted over the last three years.


Source:  outsourcing-pharma.com

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